Monkeypox vaccine: FDA authorizes change to how vaccine is given, to stretch supply

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The vaccine can now be given to high-risk adults intradermally, i.e. between the layers of the skin, rather than subcutaneously or under the skin, as was the case until recently. here. This will allow providers to get five doses from a standard single-dose vial.

The new EUA also allows for subcutaneous vaccination in people under 18 at high risk of infection.

The move could increase the number of vaccine doses in the national stockpile from 441,000 to more than 2.2 million, officials said Tuesday.

But EUA will not be a panacea as the epidemic continues to grow and demand for vaccines remains high. The United States Centers for Disease Control and Prevention has estimated that at least 1.5 million people in the United States are eligible for the two-dose vaccine.

“I think we’re going to see that we’re probably going to run out of vaccines again before we run out of weapons,” Dr. Demetre Daskalakis, the White House’s deputy national response coordinator, said on Tuesday.

The CDC reports As of Tuesday evening, 9,492 probable or confirmed cases of monkeypox in 49 states, Puerto Rico and the District of Columbia.

Move “as fast as possible”

“Over the past few weeks, the monkeypox virus has continued to spread at a rate that has made it clear that our current vaccine supply will not meet current demand,” said FDA Commissioner Dr. Robert Califf, in a press release. statement. “The FDA quickly explored other scientifically appropriate options to make the vaccine more accessible for all affected people. By increasing the number of doses available, more people who want to be vaccinated against monkeypox will now have the opportunity to do so. ”

He added during a briefing on Tuesday, “we encourage jurisdictions to use an alternative assay method as quickly as possible, and we will be your partner in this step every step of the way.”

The move comes less than a week after the Biden administration declared monkeypox a public health emergency, giving the FDA and other government health agencies more flexibility to fight the spread of the virus.

Earlier Tuesday, US Department of Health and Human Services Secretary Xavier Becerra issued his decision to clear the way for the FDA’s decision.

“Last week, I declared monkeypox a public health emergency to unlock additional tools that will help us contain and end this outbreak and signal to the American people that we are taking our response to the next level. superior,” Becerra said in a statement. “Today’s action will allow the FDA to exercise additional powers that may increase the availability of vaccines to prevent monkeypox while continuing to ensure that the vaccine meets high standards of safety, d ‘efficiency and manufacturing quality.

Prevention remains important

The CDC is launching an outreach program to ease the transition to the new strategy, expanding its education and outreach efforts for public health officials and healthcare providers. Vaccine equity will be a key part of this message, as will training and awareness on the use of the special needle for intradermal vaccination.

Gay people line up as early as 2 a.m. for monkeypox vaccines.  Many leave empty-handed.

Officials also stressed that people should continue to take steps to protect themselves from the monkeypox virus even after being vaccinated, especially those in the hard-hit population of gay and bisexual men and other men who have sex. sex with men. These include avoiding skin-to-skin contact with someone who may be infected and limiting the number of sexual partners.

“Really, monkeypox prevention is multi-domain,” Daskalakis said. “And so as people work to get vaccinated…we really want to give people clear options and advice on what to do between the first and second dose and also be aware that it takes time. after the second dose to also achieve adequate protection.”

Jynneos is given in two doses at least four weeks apart. Officials said Tuesday that people who received a first dose subcutaneously can receive the second intradermally.

The search will continue

The use of a lower dose with intradermal injection has been done with flu and rabies vaccines, epidemiologist Dr. Jay Varma told CNN in an email. Intradermal injections are also used for tuberculosis skin testing.

“The skin has special cells that are very good at helping a vaccine boost the body’s immune system,” he wrote.

These cells, called dendritic cells, are better able to mount an immune response, said Dr. Daniel Griffin, an infectious disease specialist at Columbia University.

“They live in the skin and they’re better at teaching the immune system what to respond to,” he said.

Monkeypox disproportionately affects blacks and Hispanics, according to latest CDC breakdown

A 2015 study found a similar immune response when the vaccine was given intradermally at doses one-fifth the size of those given subcutaneously. Side effects such as redness, itching and swelling were more common with the intradermal method, but there was less pain.

Jynneos has also been shown to be safe and effective in people with conditions that weaken their immune systems, Califf said Tuesday.

However, existing vaccine research focuses on the immune response of recipients, not whether it actually prevents cases of monkeypox.

“There’s no traditional evaluation of this vaccine…because there were no smallpox cases, and the outbreaks of monkeypox before that weren’t big enough to really do a clinical trial,” said Dr. Peter Marks, director of the FDA’s Center for Biologics. Assessment and Research, said Tuesday. “We want to collect outcome data, as we do with all vaccines. And I would also like to point out that the NIH will be hosting a clinical trial and is currently working on the logistics of that.”

The decision to allow the vaccination in children is based on findings regarding its use in adults, as well as data on pediatric smallpox vaccination, according to the FDA.

The agency does not allow intradermal vaccination in children for two reasons: “First, we want to make sure we get it right, and we don’t have the data in children that we have in adults. “, said Marks. “Secondly, as a medical practitioner — I know I’m not a pediatrician; I’ve treated pediatric patients on occasion — we had to give this vaccine to the younger children, and…give an injection Intradermally injecting a baby is actually a little more difficult sometimes.”

CNN’s Jeremy Diamond, Brenda Goodman and Virginia Langmaid contributed to this report.

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